MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE ADJ GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problem Leak/Splash (1354)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Type  malfunction  

Event Description

It was reported that post band placement from 2010 the patient may have a leak.A fluoro test was done within the last two weeks and was inconclusive.The patient was doing well and losing weight and now is gaining weight.It is unknown if there were any changes in the patients diet.There were no problems with fills.The fluid would go in but it is unknown where the fluid would disperse.The fill amount is unknown.It is unknown if the patient is experiencing any pain.The patient is female and bmi is unknown.The patient is scheduled for a re-op on (b)(6), 2015.

Manufacturer Narrative

(b)(4): no device received for analysis at time of submission of 3500a when additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Event occurred in 2010, exact date not provided.

Manufacturer Narrative

(b)(4).Additional information: additional information was requested and the following was obtained: what is the patients status? unknown.Will further testing be carried out to determine if there is a leak? surgery (b)(6).Has the patient and does the patient continue to follow a correct dietary regimen? unknown.Can you please provide details of the fill history? following up with customer.What is the current amount of the fill in the band? unknown.Is the surgery scheduled for band removal? (b)(6).Will the band be returned for analysis? yes.(b)(6).What is the hospital name and address? (b)(6).Can you please provide the lot number? unknown.Will check.The port was returned with locking connector attached and 9cm of catheter detached.The lot number engraved on the port is zlkbdz.1.4cm of catheter remained on the tubing connection attached with the locking connector.The hooks were in closed position.Biological debris was evident around the port.Upon microscopic evaluation 22 punctures were visible on the septum.For the leak testing, the returned catheter was reattached to the port and tested.No leaks were observed on the catheter or the port.The returned components of the device (port and partial catheter) appear to be fully functional.No definitive conclusion can be drawn as the band/balloon of the device involved in this complaint has not been returned.Product analysis (visual and functional) does not confirm the event description, the partially returned device was found to be functioning.A device history record (dhr) review was carried out and no discrepancies were recorded on file in relation to the event.The product's instructions for use were reviewed with respect to balloon leakage and it was noted to caution against inadvertent perforation of the band from sharp instrumentation during implant.It was also noted that fluid loss from the balloon can occur at any time, for a number of reasons, including general deterioration of the balloon over time.A review of the manufacturing process was performed, and it was noted that the device is 100% leak tested before release.Therefore it is unlikely that the manufacturing process caused this event.

• Brand Name: REALIZE ADJ GASTRIC BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4738592
• MDR Text Key: 5707335
• Report Number: 3005992282-2015-00018
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: RLZB32
• Other Device ID Number: 20705036004001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1